FDA Adverse Event
Other
Summary report: N
LIFESTYLES SKYN
MDR report key: 2824525
·
Received October 12, 2012
Report
- Report Number
- 1019632-2012-00011
- Event Type
- Other
- Date Received
- October 12, 2012
- Report Date
- October 12, 2012
- Manufacturer
- SURETEX LTD.
- Product Code
- HIS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
CUSTOMER INFORMED ANSELL HEALTHCARE PRODUCTS LLC THAT AFTER USING THE LIFESTYLES POLYISOPRENE LUBRICATED CONDOM, SHE HAD REPEATEDLY DEVELOPED (B)(6). SHE HAS VISITED HER REGULAR GYNECOLOGIST AND WAS PRESCRIBED THE FOLLOWING: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFESTYLES SKYN | LUBRICATED POLYISOPRENE CONDOMS | HIS | SURETEX LTD. | 1203100322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |